浅谈医疗器械行业100级洁净区的空调净化系统设计与实施

Design and Implementation of Air Conditioning System in 100 Grade Clean Area of Medical Equipment Industry

医疗器械生产车间洁净区主要包含100、10000、100000、300000四个洁净级别,其中100级洁净区更是生产车间工艺流程的核心,是无菌产品生产质量控制系统的重要组成,它对无菌产品能否实现安全有效具有至关重要的影响。随着各种新技术和新形式的出现,净化空调行业也取得了长足发展。通过采用新式的布局设计,可确保100级洁净区符合其实际生产所需。文章根据制药企业洁净厂房的生产特点,重点介绍目前实现100级洁净区的各种形式及其优缺点。

The clean area of medical device production workshop mainly includes four clean levels:100,10000,100000 and 300000.Among them,the 100 level clean area is the core of the process flow of the production workshop and an important component of the sterile product production quality control system.It has a vital impact on the safety and effectiveness of sterile products.With the emergence of various new technologies and new forms,the purification air conditioning industry has also made great progress.By adopting the new layout design,the class 100 clean area can meet the actual production needs.According to the production characteristics of clean workshop in pharmaceutical enterprises,this paper mainly introduces various forms and advantages and disadvantages of realizing 100 grade clean area.